Pres­i­dent Don­ald Trump signed an ex­ec­u­tive or­der on Wednes­day call­ing for health of­fi­cials to build a six-month stock­pile of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for "crit­i­cal" drugs in the US.

The Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse (AS­PR) with­in HHS has 30 days to com­pile a list of the ap­prox­i­mate­ly 26 drugs, ac­cord­ing to the ex­ec­u­tive or­der.

The or­der comes as the bio­phar­ma in­dus­try awaits de­tails sur­round­ing in­dus­try-spe­cif­ic tar­iffs, fol­low­ing the De­part­ment of Com­merce’s Sec­tion 232 in­ves­ti­ga­tion which start­ed in April.

There are al­so grow­ing con­cerns that drug­mak­ers could turn to cheap­er sources, like Chi­na, for raw ma­te­ri­als to ease the im­pact of US tar­iffs. This week, Ab­b­Vie de­tailed its plan to build an API fac­to­ry in the US.

Ab­b­Vie is ex­pand­ing its US man­u­fac­tur­ing foot­print with a new ac­tive phar­ma­ceu­ti­cal in­gre­di­ent plant in the works.

The com­pa­ny said Tues­day that the $195 mil­lion project will ex­pand its North Chica­go man­u­fac­tur­ing out­post and is part of the more than $10 bil­lion in planned US in­vest­ments it com­mit­ted to over the next decade. Con­struc­tion on the API fa­cil­i­ty will be­gin lat­er this year, with the site ex­pect­ed to be ful­ly op­er­a­tional by 2027.

The fa­cil­i­ty will be an added boost for drug man­u­fac­tur­ing in Illi­nois, where Ab­b­Vie is head­quar­tered and has more than 11,000 em­ploy­ees. Ab­b­Vie CEO Rob Michael de­scribed the de­ci­sion as “an im­por­tant step to main­tain U.S. lead­er­ship in phar­ma­ceu­ti­cal in­no­va­tion.”

There is the long-term threat that US tar­iffs could lead In­di­an gener­ic drug­mak­ers to move back to get­ting most of their APIs from Chi­na, which runs counter to the broad­er in­dus­try’s vi­sion of di­ver­si­fy­ing where they get their raw ma­te­ri­als.

One rea­son for the US’ phar­ma-spe­cif­ic levies is to reshore drug pro­duc­tion to the US, in­clud­ing APIs. But there is the con­cern that the US would not be com­pet­i­tive soon enough and that gener­ic drug man­u­fac­tur­ers would go to Chi­na for most of their raw ma­te­ri­als, said Mar­ta Wosińs­ka, se­nior fel­low of eco­nom­ic stud­ies at The Brook­ings In­sti­tu­tion.

Sup­ply of Sanofi’s cho­les­terol drug Pralu­ent is lim­it­ed in Chi­na due to an in­crease in de­mand, the French phar­ma told End­points News on Tues­day.

“Sanofi has worked with pa­tients and health­care pro­fes­sion­als, as well as in­vest­ed to strength­en glob­al pro­duc­tion of Pralu­ent, to meet a ris­ing glob­al de­mand which ac­cel­er­at­ed sharply over the past two years. The surge in de­mand has led to lim­it­ed avail­abil­i­ty in Chi­na, and some oth­er coun­tries,” a com­pa­ny spokesper­son said in an email.

Sanofi gave no de­tails on when, or if, sup­ply of Pralu­ent will re­cov­er in Chi­na.

Pralu­ent is a PC­SK9 in­hibitor an­ti­body giv­en sub­cu­ta­neous­ly to pa­tients ei­ther every two or four weeks. Sanofi and its part­ner Re­gen­eron se­cured FDA ap­proval for Pralu­ent in Ju­ly 2015. Af­ter re­struc­tur­ing the part­ner­ship in April 2020, Sanofi has been re­spon­si­ble for sup­ply­ing Pralu­ent out­side of the US, while Re­gen­eron con­trols dis­tri­b­u­tion in­side the US.

De­spite a re­cent ap­proval in Eu­rope, Au­to­lus Ther­a­peu­tics does not ex­pect to sell its blood can­cer cell ther­a­py in the re­gion un­til 2027 and specif­i­cal­ly not­ed that its Ger­man launch plans are on hold.

The CD19-tar­get­ed cell ther­a­py called Au­catzyl was green­lit by the Eu­ro­pean Com­mis­sion for re­lapsed or re­frac­to­ry B cell pre­cur­sor acute lym­phoblas­tic leukemia last month, fol­low­ing a pos­i­tive opin­ion from the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) in May.

How­ev­er, the biotech doesn’t an­tic­i­pate any Eu­ro­pean sales this year or next, as the path to mar­ket ac­cess in Eu­rope of­ten re­quires da­ta from ran­dom­ized con­trolled stud­ies. This presents a chal­lenge for treat­ments like its cell ther­a­py, which was eval­u­at­ed in sin­gle-arm reg­is­tra­tional tri­als, Au­to­lus CEO Chris­t­ian Itin said on a Tues­day earn­ings call with an­a­lysts.

The FDA is con­sid­er­ing re­vok­ing Pfiz­er's emer­gency use au­tho­riza­tion for its Covid-19 vac­cine for chil­dren aged 6 months through 4 years, the com­pa­ny said in a state­ment to End­points News.

"We are cur­rent­ly in dis­cus­sions with the agency on po­ten­tial paths for­ward and have re­quest­ed that the EUA for this age group re­main in place for the 2025-2026 sea­son," a Pfiz­er spokesper­son said. "It is im­por­tant to note that these de­lib­er­a­tions are not re­lat­ed to the safe­ty and ef­fi­ca­cy of the vac­cine which con­tin­ues to demon­strate a fa­vor­able pro­file."

An HHS spokesper­son told End­points the com­pa­ny's com­ment was "pure spec­u­la­tion."

Po­ten­tial changes to who can get Pfiz­er and BioN­Tech's mR­NA-based Covid vac­cine, if they go through, would align with oth­er re­cent re­stric­tions for Covid-19 shots that HHS has put in place since Robert F. Kennedy Jr. took the helm of the agency in Feb­ru­ary.